Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013

摘要

Continuous standardized verification of the accuracy of blood glucose meter systems for self-monitoring after their introduction into the market is an important clinically tool to assure reliable performance of subsequently released lots of strips. Moreover, such published verification studies permit comparison of different blood glucose monitoring systems and, thus, are increasingly involved in the process of evidence-based purchase decision making.